No “One Size Fits All”Solution to Improve Clinical Trial Participation

By Kathleen Hoffman, PhD, MSPH
Clinical trial study designers are trying to find ways to increase participation and reduce dropout. According to three recent studies, the reasons patients give for not participating in clinical trials vary depending on a number of factors including the condition being studied, the gender or age of participants, and even minority status. Accommodating these differing needs in the study design would support enrollment and sustain participation, but it requires asking prospective participants what would lower the barriers for their specific condition first.

Encouraging parents to enroll a child in pediatric studies poses particular difficulties. In a study published by Contemporary Clinical Trials Communications in 2018, Parents’ perceived obstacles to pediatric clinical trial participation: Findings from the Clinical Trials Transformation Initiative, researchers gained insight on what would improve parental consent. The study found that “…parents’ priorities and considerations must be a central focus, beginning with initial trial design.”1

One area of particular difficulty involved encouraging parents of infants to participate in trials. “Several parents of premature newborns thought that the investigators who approached them about clinical trial participation were primarily focused on filling study slots and not focused enough on showing empathy for the parents or concern for the infants.” Their conclusion? Training researchers on interpersonal factors may open the door. “Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents’ decisions.”1 Something as simple as adding evening or weekend opportunities could improve enrollment.

Minorities are another understudied population. In Training Needs of Clinical and Research Professionals to Optimize Minority Recruitment and Retention in Cancer Clinical Trials, the authors concluded that the barriers aren’t always eligibility criteria; researchers also need cultural awareness. Their study found that “training that focuses on increasing cultural awareness [could] increase the participation of minorities in clinical trials.”2

A review of studies on women with cardiovascular disease published in the Journal of the American College of Cardiology, Participation of Women in Clinical Trials, found that women are under-represented in FDA drug trials for high-risk cardiac conditions including ischemic heart disease and heart failure trials — which are the most common cardiovascular conditions affecting women. In an editorial comment, the authors said, “among the hypothesized barriers to participation of women in research, gender-related factors, such as caretaking roles and low socioeconomic status, should be considered as main barriers to enrollment and women’s willingness to participate in clinical trials.” These are the hypothesized barriers. Women need to be asked what the real barriers include.

Inspire members — patients and caregivers — regularly share information, experiences, and concerns about clinical trial participation. One Inspire member considering joining a trial was concerned about side effects and said, “People in the medical profession urge me to join. Friends and family mostly discourage me, especially a friend who [believed a drug caused them to contract a condition].” Another member was concerned about her quality of life and travel: “I live in the sticks …, I really want to be cured so maybe I can make my life better but I’m scared too that [traveling to participate] could be too much for me.” A lack of communication from researchers or buy-in from caregivers also affected willingness to join.

As the studies and Inspire members demonstrate, there is no “one size fits all” solution to lowering the barriers to clinical trial participation. Clinical trial enrollment can be improved by researching the patient experience as part of trial design. As the authors of the pediatric study found, to understand what would spur a particular segment to say “yes,” you have to ask what’s missing and what would help.

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2Niranjan, S.J., Durant, R.W., Wenzel, J.A. et al. J Canc Educ (2019) 34: 26.